FDA 483 - Hubei Gedian Humanwell Pharmaceutical Co., Ltd.

This FDA Form 483 was issued to Hubei Gedian Humanwell Pharmaceutical Co., Ltd. in Ezhou, China, an API and API intermediate manufacturer, following an inspection from May 9-13, 2016. The inspection revealed two observations related to inadequate calibration of equipment and failure to follow cleaning procedures for sampling rooms. These issues indicate deficiencies in quality control and adherence to standard operating procedures.